NCT03966027

Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Kyle Schweser MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores

Detailed description

Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores Patients will be recruited from the trauma and foot \& ankle service lines. Patients who have experienced an isolated ankle fracture (excluding pilon fracture) and will undergo operative fixation within 3 weeks of injury will be approached for consent. Patients will then be screened based on the inclusion and exclusion criteria. Up to 25 patients will be enrolled The following protocol will be applied after enrollment 1. Pre-operatively a. Hemoglobin A1c will also be collected from each patient if it has not been performed within the last 30 days. 2. Post-operatively a. Post-surgery i. Standard of Care: 1\. Placement into short leg, non-weight bearing splint to allow for wound healing and brace fabrication ii. Research Specific: 1\. Fitted for brace (will be custom made and take approximately 1-2 weeks) b. 2 week visit (standard of care timepoint) i. Standard of Care: 1. Placed into compression stockings 2. Counseling regarding skin checks and diabetic skin care 3. Physical therapy prescription given ii. Research Specific 1\. Placement into brace so it offloads the hindfoot to 15 pounds of pressure or less 2. Education by prosthetist, physiatrist, and/or attending physician about proper brace wear and maintenance, and the importance of weight bearing only in brace. c. 3 Week visit (not standard of care timepoint) i. Research Specific 1\. Ankle radiographs d. 4 weeks, 6 weeks, 12 Weeks, 26 weeks, and 1 year visits (standard of care time points) i. Standard of Care 1. Surveys (PROMIS, AAOS Foot and Ankle) 2. Ankle Radiographs ii. Research Specific 1\. Counseling regarding brace wear 2. Brace adjustments as needed e. 8 week, 10 week, 14 week, 16 week, (non-standard of care biweekly visits until healing occurs) i. Research Specific 1. Ankle Radiographs (if early failure is suspected) 2. Skin Check Upon study completion, patients will continue with post-operative rehab following the surgeon's standard of care. If a patients is removed prematurely or if the study ends prematurely, they will receive standard of care procedures going forward

Conditions

• Ankle Fractures

Interventions

Type	Name	Description
OTHER	Postoperative protocol (Immediate weight bearing)	After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace
OTHER	Postoperative Protocol (Delayed Weight Bearing)	After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol

Timeline

• Start date: 2020-08-01
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2019-05-29
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States